Jay D. Amsterdam and Leemon B. McHenry : The Paroxetine 352 Bipolar Study Revisited : Desconstruction of Corporate and Academic  Misconduct 

Jay Amsterdam and Leemon McHenry’s reply to Edward Tobe’s comment

        We thank Professor Tobe for his thoughtful and insightful commentary on our deconstruction of the newly-posted Scientific Therapeutics Information (STI) documents pertaining to the paroxetine 352 bipolar depression trial, published in the American Journal of Psychiatry in 2001 as “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression,” in the names of Charles Nemeroff, Dwight Evans, Laszlo Gyulai and five others.

        The STI documents portray a tangled web of editorial and academic malfeasance, data manipulation and data suppression achieved via corporate-sponsored ghostwriting.  It is what in 2009 the editors of PLoS Medicine called “The Dirty Little Secret of Medical Publishing.” The mis-reporting of clinical trials has led to significant harm to patients and the integrity of evidence-based medicine (Jureidini and McHenry 2020).

        Despite overwhelming evidence of fraud as a result of high-profile litigation and whistleblower allegations, misleading conclusions about clinical data remain part of the medical literature for many widely-prescribed psychotropic medications (including paroxetine, one of the most widely-prescribed antidepressants in the United States).

        The very idea of academics corrupting their own literature is unthinkable in other disciplines. Why does it persist in medicine?  And why would universities, as the guardians of truth and the moral conscience of society, compromise their basic academic values that result from the collaborations with industry?

        Dr. Tobe may have his finger on the pulse of the psychodynamic underpinnings of the problem when he asks:

        “What  allows  a culture of scientific misconduct to exist? One answer is that those involved in fraud can be rewarded in socioeconomic and academic  stature.”

He continues:

         “Culture is created by a social group… to become part of a group, the individual needs to shed some element of autonomy to merge with the group. A group may search for an enemy to enhance their union. The human species has a readiness to form groups and expel those not accepting the group’s values and beliefs; however, unquestioning acceptance of  the group’s values and actions is an act of blind faith and potentially  disassociation  from   reality…

        “Those  involved  in  misconduct  in  medical  science either  ignore  or  disregard  the  possible  harm  to  the  patient  to  remain loyal to the group. The denial of misconduct may reflect  fears  of  emotional  disquiet.  External  pain  occurs through  public  exposure  leading  to  social  and  legal ramifications.  Internal  pain  results  from  shame,  which  is concealed or warded off by enhanced righteous arrogance. In the case of systematic medical fraud involving numerous people,  some  of  whom  gained  prominence  in  their  own  mind,  their  idealized  self  needs  to  love  their  lie,  as  the alternative is to face their shame.”

        In other words, those involved in the misconduct need to envelop themselves in a patina of morality as if their actual behavior benefits humanity.  In our opinion, this is only another example of self-deception and the sense of entitlement that is common among those identified as key opinion leaders (KOLs) in pharmaceutical industry collaborations.   The behavioral psychologists might refer to this behavior as demonstrating “cognitive dissonance,” whereby KOLs can clearly see the immorality in others’ behavior while justifying the same behavior as moral for themselves.

        Even given the overwhelming evidence of fraud, deception, ghostwriting and data manipulation provided by publicly-available documents, like those of the STI documents, scientific articles resulting from these fraudulent data are rarely retracted by the scientific journals that originally publish them. This is certainly the case with the paroxetine 352 American Journal of Psychiatry  article.

        It is our hope that public awareness of scientific misconduct in clinical trials reporting and investigative transparency (via publication of evidence such as the STI documents) will help to correct the medical literature.  However, to this day, the published 352 Paroxetine trial report in the American Journal of Psychiatry has not been retracted, despite calls from the academic community for its retraction.

References:

PLoS Medicine Editors. Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger. PLoS Med. 2009; 6(9):e1000156.

Jureidini J, McHenry LB.  The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research. Adelaide: Wakefield Press, 2020. 

September 24, 2020